2005/34/EC: Commission Decision of 11 January 2005 laying down harmonised standards for the testing for certain residues in products of animal origin imported from third countries (notified under document number C(2004) 4992)Text with EEA relevance
Date: 2005-01-11
Institutions: European Commission
Subjects: animal product, harmonisation of standards, import, originating product, pharmaceutical product, qualitative analysis, research body, third country, veterinary inspection

20.1.2005

EN

Official Journal of the European Union

L 16/61

COMMISSION DECISION

of 11 January 2005

laying down harmonised standards for the testing for certain residues in products of animal origin
imported from third countries

(notified under document number C(2004) 4992)

(Text with EEA relevance)

(2005/34/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 97/78/EC of 18 December
1997 laying down the principles governing the organisation of
veterinary checks on products entering the Community from
third countries (1), and in particular Articles 4(5) and 17(7)
thereof,

Having regard to Regulation (EC) No 882/2004 of the European
Parliament and of the Council of 29 April 2004 on official
controls performed to ensure the verification of compliance
with feed and food law, animal health and animal welfare
rules, and in particular Articles 11(4) and 63(1)(e) thereof,

Whereas:

(1)

(2)

that

each consignment
Directive 97/78/EC requires
imported from third countries
to
veterinary controls. These checks may include analytical
tests for residues of pharmacologically active substances
in order to verify whether the consignments fulfil the
requirements of Community legislation.

shall be subject

The maximum residue limits (MRL) to be applied in food
control according to Council Directive 96/23/EC of 29
April 1996 on measures to monitor certain substances
and residues thereof in live animals and animal products
and repealing Directives 85/358/EEC and 86/469/EEC
and Decisions 89/187/EEC and 91/664/EEC (2), have
been established for pharmacologically active substances
by Council Regulation (EEC) No 2377/90 of 26 June
1990 laying down a Community procedure for the estab-
lishment of maximum residue
limits of veterinary
medicinal products in foodstuffs of animal origin (3).
MRLs are applicable to imported consignments.

(1) OJ L 24, 30.1.1998, p. 9. Directive as last amended by Regulation
(EC) No 882/2004 of the European Parliament and of the Council
(OJ L 165, 30.4.2004, p. 1).

(2) OJ L 125, 23.5.1996, p. 10. Directive as last amended by Regulation

(EC) No 882/2004.

(3) OJ L 224, 18.8.1990, p. 1. Regulation as

(EC) No 2232/2004 (OJ

last amended by
L 379,

Commission Regulation
24.12.2004, p. 71).

However, Regulation (EEC) No 2377/90 does not provide
MRLs for all substances and in particular not for those
substances whose use is prohibited or not authorised in
the Community. For those substances, the presence of
any residue may present grounds to reject or destroy
the relevant consignment at import.

It is appropriate that the Community should establish a
harmonised approach for
in imported
consignments of residues of substances prohibited or
not authorised in the Community.

control

the

The minimum required performance limits (MRPLs) set
according to Commission Decision 2002/657/EC of 12
August 2002 implementing Council Directive 96/23/EC
concerning the performance of analytical methods and
the interpretation of results (4) have been adopted as
the standard of performance ensuring effective control
of Community legislation when testing official samples
for the presence of certain prohibited or unauthorised
substances; the MRPL correspond to the average limit
above which the detection of a substance or
its
residues can be construed as methodologically mean-
ingful.

the

establishing

European
Regulation (EC) No 178/2002 of
Parliament and of
the Council of 28 January 2002
laying down the general principles and requirements of
food law,
the European Food Safety
Authority and laying down procedures in matters of
food safety (5),
in line with the Codex alimentarius
Working Principles for Risk Analysis (6), requires food law
to be based on factors legitimate to the matter under
consideration, such as feasibility of controls.

the
below the MRPLs

isolated detection of
set

residues of
a
Therefore,
substance
by Decision
2002/657/EC should be construed as not of immediate
concern but to be monitored by Member States and the
MRPLs should be employed where they exist, as the
reference point for action to ensure a harmonised imple-
mentation of Directive 97/78/EC.

(4)

(5)

(6)

(7)

(4) OJ L 221, 17.8.2002, p. 8. Decision as last amended by Decision

2004/25/EC (OJ L 6, 10.1.2004, p. 38).

(5) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Regulation

(EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

(6) Available on ftp://ftp.fao.org/codex/alinorm03/Al03_33e.pdf

L 16/62

EN

Official Journal of the European Union

20.1.2005

(8) Where the results of analytical tests indicate the presence
of residues of a substance for which MRPLs have been
established in accordance with Decision 2002/657/EC,
and pending the implementation of Regulation (EC) No
882/2004 on 1 January 2006, it is appropriate to clarify
the action to be taken,
taking into consideration the
seriousness of the threat which the consignment may
represent
laid
down in Directives 96/23/EC and 97/78/EC and in Regu-
lation (EC) No 178/2002.

to human health, and the provisions

Article 3

Action in case of confirmed presence of a prohibited or
non-authorised substance

1. Where results of analytical tests are at or above the MRPLs
consignment
laid down in Decision 2002/657/EC,
concerned
with
be
Community legislation.

non-compliant

considered

shall

the

(9)

(10)

Member States should in particular monitor the import
situation for any evidence of a recurrent problem, since
such a finding could suggest a pattern of misuse of a
particular
a disregard for guarantees
provided by third countries concerning the production
into the Community.
import
of
Member States
the Commission of
should notify
recurring problems.

food intended for

substance, or

The measures provided for by this Decision are in
conformity with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

HAS ADOPTED THIS DECISION:

Article 1

Scope of the Decision

1.
This Decision lays down the reference points for action
for residues of substances for which MRPLs have been estab-
lished in accordance with Decision 2002/657/EC when
analytical tests carried out pursuant to Directive 97/78/EC on
imported consignments of products of animal origin confirm
the presence of such residues, and the action to be undertaken
after such confirmation.

2.
This Decision applies whether analytical tests are carried
out routinely, under reinforced checks procedures or under a
safeguard measure on consignments of products of animal
origin imported from third countries.

2.
Pending the application from 1 January 2006 of Articles
19 to 22 of Regulation (EC) No 882/2004, the competent
the Member States shall place under official
authorities of
detention non-compliant consignments from third countries,
and having heard the food business operators responsible for
the consignment, shall take the following measures:

(a) order that such consignments be destroyed or re-dispatched
outside the Community in accordance with paragraph 3;

(b) if the consignments have already been placed on the market,
recall the consignments before taking one of the measures
referred to above.

The competent authorities

3.
consignments only if:

shall allow re-dispatch of

(a)

the destination has been agreed with the feed or food
business operator responsible for the consignment; and

(b) the food business operator has first informed the competent
authority of the third country of origin or third country of
destination,
if different, of the reasons and circumstances
preventing the placing on the market of the consignments
concerned within the Community; and

(c) when the third country of destination is not
the competent authority of

the third
the third
country of origin,
country
competent
authority of its preparedness to accept the consignments.

destination has notified

the

of

Article 2

Reference points for action

For the purpose of control of residues of certain substances
whose use is prohibited or not authorised in the Community,
the minimum required performance limits (MRPLs) laid down in
Annex II to Decision 2002/657/EC shall be used as reference
points for action irrespective of the matrix tested.

4. Without prejudice to the national rules of Member States
concerning the review of administrative decisions, a re-dispatch
shall take place no more than 60 days after the day on which
the competent authority decided on the destination of
the
consignment, unless legal action has been undertaken. If, after
the expiry of the 60-day period, re-dispatch does not take place,
the consignment shall be destroyed, unless the competent
authority is satisfied that a delay is justified.

20.1.2005

EN

Official Journal of the European Union

L 16/63

5. Where the results of analytical tests on products are below
the MRPLs laid down in Decision 2002/657/EC, the products
will not be prohibited from entering the food chain. The
competent authority shall retain a record of the findings in
tests on
case of recurrence. Where the results of analytical
products from the same origin show a recurrent pattern indi-
cating a potential problem related to one or several prohibited
or unauthorised substances, including for instance the recording
of four or more confirmed results below the reference points
for action for the same substance in imports from a particular
origin within a period of six months, the competent authority
shall inform the Commission and the other Member States in
the Standing Committee on the Food Chain and Animal Health.
The Commission shall bring the matter to the attention of the
competent authority of the country or countries of origin and
shall make appropriate proposals.

6.
The feed or food business operator responsible for the
consignment or its representative shall be liable for the costs

incurred by competent authorities for the activities referred to in
paragraph 1 to 4 of this Article.

Article 4

This Decision shall apply from 19 February 2005.

Article 5

This Decision is addressed to the Member States.

Done at Brussels, 11 January 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission